Dermazin Micronized Silver Sulfadiazine Cream

DERMAZIN®

 

COMPOSITION

Each 100 g of cream contains 1 g of micronized silver sulfadiazine in a hydrophilic base.

 

ACTION

Dermazin is a local chemotherapeutic for prevention and treatment of burn wound infections.

Silver sulfadiazine disintegrates in the burn wound, thereby causing a slow and sustained release of silver ions. Silver ions bind to bacterial desoxyribonucleic acid, thus inhibiting the growth and multiplication of bacterial cells without affecting the cells of the skin and subcutaneous tissue. Dermazin cream has a broad antibacterial spectrum including virtually all microbial species likely to infect the burn wound: Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, strains of Proteus and Klebsiella; it is also effective against Candida albicans and other fungi. Dermazin penetrates into the necrotic tissue and exudate. This effect is very important in view of the fact that systemic antibiotics are not effective against the bacterial flora of the avascular burn necrosis.

 

INDICATIONS

Treatment and prevention of burn wound infections and infected dermal defects, including bed sores and deep neglected wounds.

 

CONTRAINDICATIONS

The use of Dermazin is contraindicated in premature infants and neonates because of possible kernicterus. Dermazin should not be used in pregnancy, except in cases when the potentially lifesaving benefits of the medication outweigh possible hazard to the fetus.

 

PRECAUTIONS

Caution is required in the presence of hypersensitivity to sulfonamides because of possible allergic reactions, in patients with inborn glucose-6-phosphate dehydrongenese deficiency, as hemolysis may occur after the application of the cream to the large body surface area, as well as in the presence of hepatic and renal dysfunction. When treatment with Dermazin cream involves prolonged administration or large burn surfaces, the white blood cell count should be monitored, as leukopenia may occur.

 

WARNING

Elevation of body temperature occurring in children during the first days of treatment is unrelated to Dermazin administration and should not lead to the discontinuation of therapy.

Keep out of reach of children.

 

SIDE EFFECTS

In prolonged treatment of burn wounds involving extensive areas of the body the serum sulfonamide concentrations may approach the levels equal to those in systemic treatment.

 

DOSAGE AND ADMINISTRATION

An appropriate treatment regimen is promptly instituted after evaluating the extent and depth of the burn wound. After the burned area is cleaned and debrided, Dermazin cream is applied to a thickness of 2-4 mm to the burned area or, preferably, the cream is applied to sterile gauze which is placed over the burn wound. The cream is applied by a sterile spatula or gloved hand. The burned areas are usually covered with the cream once daily; in severe burn wounds the cream is reapplied daily.

Duration of superficial burn treatment depends on the injury ranging from several days to one month at the most. Surgery is required only if no healing occurs after one month of treatment with Dermazin. Prior to each reapplication of the cream, the burn should be washed in shower or with an antiseptic solution to remove remnants of cream and wound exudate which are abundant after Dermazin application, resembling pus in colour but actually aseptic. Dermazin cream in jars intended for repeated application in one patient only. The application of the cream is painless. It does not stain clothes and bed linen.

 

PRESENTATION

Tubes of 25 g of cream.

Tubes of 50 g of cream.

Jars of 250 g of cream.

Jars of 500 g of cream.

 

Manufactured by

Salutas Pharma GmbH

39171 Osterweddingen, Germany.

 

Marketing authorisation Holder

Taylek Drugs Co. Ltd., Plot 8 Block ‘M’,

Abimbola Street, Isolo, Lagos – Nigeria.

Gentalek Gentamycin Product Characteristics

Gentalek Gentamycin Product Characteristics

The following information is intended for medical or health care providers only (short summary of product characteristics).

The solution is colourless to almost colourless, clear and free of visible particulate matter. Prior to administering, the solution for injection/infusion is to be carefully inspected to make sure, it is clear, does not contain precipitates and has not chnaged its colour. If the appearance of the product is changed do not use the solution for injection/infusion.

 

Incompatibilities

Beta-lactam antibiotics in vitro may inactivate gentamicin; therefore, they should not be mixed in the same infusion bottle for intravenous administration.

Penicillin should not be mixed directly with gentamicin due to physical and chemical incompatibility.

Gentamicin may be inactivated by some beta-lactam antibiotics in vitro and less frequently in vivo. This reaction is significant particularly when using carbenicillin and ticarcillin together with gentamicin. The reaction occurs mainly in vitro therefore, gentamicin and beta-lactam antibiotics should not be mixed in the same syringe or infusion bottle.

 

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

Gentamicin for short-term intravenous infusion is to be diluted

– in 100 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.

– or glucose 50 mg/mI (5%) solution or infusion.

The concentration of gentamicin in the solution should not exceed 1 mg/ml.

 

Posology and administration

Gentamidn is intended for intramuscular as well as intravenous administration. The dose, route of administration and interval between individual doses depend on the type and severity of the infection, the susceptibility of the microorganism and the patient’s condition (age, renal function).

Administration of the product as a single daily dose produces a stronger antibacterial effect due to a higher concentration of gentamicin. The antibacterial effect of the following dose is also more expressed due to a prolonged interval.

The exact dose is determined on the basis of the patient’s body weight. The medicine should not be administered as a single daily dose in patients with impaired immunity, severe renal impairment, infective endocarditis and in pregnant women.

Adults and children above 12 years of age: The usual daily dose of gentamicin in patients with moderate infections is 3 mg/kg body weight, administered intramuscularly or intravenously and divided into one to three doses. The usual dose in patients above 60 kg with normal renal function is 80 mg every 8 hours. In severe infections the dose is increased to 5 mg/kg daily.

Infants and children from 1 to 12 years of age: 4.5 mg to 6 mg/kg/day intramuscularly or intravenously, divided into one to three doses.

Newborn infants older than one week and infants up to one year of age: 6 mg/kg/day intramuscularly or intravenously divided into two doses (administered every 12 hours).

Newborn infants in the first week of life: 5 mg/kg/day intramuscularly or intravenously divided into two doses (administered every 12 hours).

Newborn infants should be given gentamicin only in urgent cases. The treatment should be as short as possible.

In newborn infants, infants and in children being administered equal doses determined on the basis of their body weight, serum concentrations of gentamicin are lower than in adults; consequently, the doses are slightly higher. It is recommended to determine serum concentrations of gentamicin every day. The serum concentration of gentamicin one hour after administration should be at least 4 micrograms/ml.

 

Administration in renal Impairment

An altered dosage schedule of gentamicin is required in the presence of renal failure. The initial dose is the same as in patients with normal renal function; however, during the continuation of the treatment the interval between individual doses should be prolonged.

As the aminoglycoside clearance is highly correlated with the creatinine clearance, the required gentamicin dose may be calculated on the basis of creatinine clearance values.
The following table provides the recommended dosage schedules in patients with impaired renal function:

Urea
mg/100 ml
Creatinine clearance
(ml/s)
Doses and dosage
interval
< 40 > 1.2 80* mg every 8 hours
40 – 100 0.5 – 1.2 80* mg every 12 hours
100 – 200 0.2 – 0.5 80*mg every 24 hours
> 200 0.1 – 0.2 80* mg every 48 hours
haemodialysis
twice a week
< 0.1 80 mg after dialysis

* in patients weighing less than 60 kg, 60 mg of gentamicin should be administered.
When determining gentamicin doses, it should be borne in mind that these doses are only approximate and that equal doses may produce different concentrations in different patients. Consequently, serum gentamicin concentrations should be determined and the doses should be adjusted accordingly. The serum level of gentamicin 30 to 60 minutes after intravenous or intramuscular application should be 5 – 10 micrograms/ml.
1 to 1.5 mg of gentamicin per kg body weight should be administered at the end of haemodialysis. In peritoneal dialysis, 1 mg of gentamicin should be added to 2 litres of dialysis solution.

 

Elderly patients

In elderly patients, the half-life of gentamicin is prolonged due to a decreased glomerular filtration rate. The decreased glomerular filtration rate in elderly patients is not always manifested in higher levels of serum creatinine. Consequently, the creatinine clearance should be determined in elderly patients in order to calculate the gentamicin dose.

 

Method of intravenous administration

The doses are identical as in intramuscular administration.

Gentamicin should be administered directly intravenously in a slow manner (3-5 minutes, though no longer than 15 minutes) or as a slow infusion (30-60 minutes). The maximum dose for direct intravenous administration in adult patients is 80 mg of gentamicin; if the dose is higher, a short-term infusion is required.

When Gentamicin is administered as a short-term infusion, the usual quantity of the solvent (sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for infusion) is 100 ml in adults and proportionately less in children, depending on the dose. The concentration of gentamicin in the infusion is 20-30 minutes when the medicine is administered several times a day.

When the medicine is administered as a single daily dose, the duration of infusion is 30-60 minutes.

The maximum daily dose of gentamicin is 7.5 mg/kg divided into three doses.

Gentalek Gentamycin Solution for Injection and Infusion

Gentalek 80 mg/2 ml solution for injection/infusion

Gentamycin

 

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.

• If you have further questions, please ask your doctor or pharmacist.

• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

 

In this leaflet:

1. What Gentalek is and what it is used for.

2. Before you use Gentalek.

3. How to use Gentelek.

4. Possible side effects.

5. Storage of Gentalek.

6. Further information.

1. WHAT GENTLEK IS AND WHAT IT IS USED FOR

Gentalek is an antibiotic of the aminoglycoside group. It is effective against some Gram-positive bacteria and particularly effective in infections caused by Gram-negative bacteria.

Gentalek is intended for the treatment of severe infections such as:

– Sepsis, including neonatal sepsis,

– severe, recurrent urinary tract infections,

– infections of the lower respiratory tract,

– infections of the skin and soft tissues,

– infections of the central nervous system, including meningitis (inflammation of the brain membranes) in combination with topical administration,

– bone and joint infections,

– endocarditis (inflammation of the inner layer of the heart),

– infections of burns, traumatic and surgical wounds,

– infections in the abdomen and their prevention, particularly after surgical procedures in the urinary and intestinal tract.

Gentamicin is also the drug of choice in the treatment of severe bacterial infections caused by unidentified agents, and in infections which occur simultaneously with diseases which severely diminish the immune system of the body, e.g. leukemia, diabetes, corticosteroid therapy. In such cases gentamicin is usually used in combination with beta-lactam antibiotics.

 

2. BEFORE YOU ARE GIVEN GENTALEK

You should not be given Gentalek if you

– are allergic (hypersensitive) to gentamicin or to any of the other ingredients of Gentalek (see section 6 – Further Information),

– are allergic to other aminoglycoside antibiotics,

– have neurological disorder called myasthenia gravis.

 

Your doctor will take special care when giving Gentalek

– if you suffer from impaired kidney function,

– if you have auditory disorders or tinnitus,

– if you have vestibular disorders or vertigo

– if you have Parkinson’s disease,

– if you suffer from calcium, potassium or magnesium deficiency,

– if you are dehydrated,

– if you are older than 65 years,

– if the medicinal product is intended, for the treatment of a neonate.

Tell your doctor if any of these conditions exist.

 

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal remedies, strong vitamins and minerals. Furthermore, do not take any new medicine without consulting your doctor.

Gentalek may interact with other medicines and influence their effects and/or cause side effects. This applies particularly to the following medicines:

– diuretics (water pills – ethacrynic acid and furosemide),

– muscle relaxants,

– other antibiotics which may cause auditory and vestibular disorders or renal impairment, especially streptomycin, neomycin, kanamycin, tobramycin, cephaloridine, paromomycin, viomycin, polymyxin B and colistin, amikacin, vancomycin, clindamycin, piperacillin,

– amphotericin B (for treating fungal infections),

– cyclosporin, tacrolimus (post-organ transplant medicine),

– methoxyflurane (anaesthetic),

– foscarnet, cidofovir (for treating viral infections),

– intravenous radioactive agents,

– cisplatin (for treating some forms of cancer),

– succinylcholine, tubocurarine (neuromuscular blocking agents).

 

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Gentalek must not be used during pregnancy, except in urgent cases. Gentamicin should be used during pregnancy only in life-threatening situations when no other suitable antibiotic is available.

Because of the potential for adverse effects in the breast-fed infant, breast-feeding is not recommended.

Driving and using machines

There is no known effect of Gentalek on the ability to drive or use machines.

In some individuals, large doses of Gentalek may cause vestibular disorders accompanied by nausea and vertigo. The condition may worsen after the discontinuation of treatment.

Ask your doctor for advice if such disorders occur.

 

Important information about some of the ingredients of Gentalek

The medicine contains preservatives methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). They may cause allergic reactions (possibly delayed) and exceptionally, bronchospasm (difficulty breathing with wheezing or coughing). The medicine contains stabilizer sodium metabisulfite (E223): It may rarely cause severe allergic reactions and bronchospasm.

The medicine contains sodium: it contains less than 1 mmol (23 mg) of sodium per dose, which essentially means it is “sodium-free”.

 

3. HOW TO USE GENTALEK

The medicine will be given to you by a doctor or nurse, as it is injected in the muscle (intramuscular administration) or the vein (intravenous administration). Gentalek may also be administered in the form of intravenous infusion. The dose, route of administration and intervals between doses will be determined by the doctor. The medicine will be administered one to three times a day.

Usual dosage (normal kidney function)

Adults and children above 12 years of age: The usual daily dose of gentamicin in patients with moderate infections is 3 mg/kg body weight, divided into 1 to 3 doses. It is administered intramuscularly or intravenously. The usual dose in patients above 60 kg with normal renal function is 80 mg every 8 hours. In severe infections the dose is increased to 5 mg/kg daily.

Infants and children from 1 to 12 years of age: 4.5 mg/kg/day intramuscularly or intravenously, divided into 1 to 3 doses.

Newborn infants older than one week and infants up to one year of age: 6 mg/kg/day divided into 2 doses (administered every 12 hours).

Newborn infants in the first week of life: 5 mg/kg/day intramuscularly or intravenously, divided into 2 doses (administered every 12 hours).
Newborn infants are given Gentalek only in urgent cases. The treatment should be as short as possible. The doctor will determine the treatment.

Dosage in kidney Impairment

An altered dosage schedule of gentamicin is required in the presence of renal failure. The initial dose is the same as in patients with formal renal function; however, during the continuation of the treatment the interval between individual doses should be prolonged. Your doctor will adjust the dose of medicine accordingly.

Dosage in patients above 65 years of age

If you are above 65 years of age, the doctor will adjust the dosage according to your renal function.

Since equal doses of gentamicin may produce different concentration in different patients, serum gentamicin concentrations should be determined and the doses should be adjusted accordingly. The doctor or nurse will take a blood sample to determine the serum concentration of the medicinal product.

The maximum daily dose of gentamicin is 7.5 mg/kg divided into three doses.

 

If you are given more Gentalek than you should (overdose)

As Gentalek will be administered by a doctor or nurse, overdose is highly unlikely. Immediately inform your doctor if you notice signs of overdose (adverse effect on the vestibular (balance) and auditory (hearing) system, kidney impairment – severely decreased urine output, muscle weakness or difficulty breathing). Gentamicin is removed from the blood using haemodialysis. Exchange transfusion is suitable in newborn infants.

Removal of gentamicin is particularly important in patients with impaired kidney function.

 

If you do not receive Gentalek at the scheduled time

It is highly unlikely that you will not receive the medicinal product at the correct time prescribed by the doctor. Inform the doctor or nurse if you believe a dose has been missed.

Ask your doctor if you have any further questions.

 

4. POSSIBLE SIDE EFFECTS

Like all medicines, Gentalek can cause side effects, although not everybody gets them. The following side effects have been reported.

Uncommon (may occur in fewer than 1 in 100 patients): auditory disorder, vestibular disorder, sensation of pressure or ringing in the ears, vertigo, involuntary eye movement (nystagmus), nausea, vomiting, increased blood urea and creatinine levels.

Gentalek may impair auditory function, particularly with the concurrent presence of renal impairment. Inform your doctor if you notice newly occurring changes, e.g. vestibular (balance) disorders, vertigo, auditory (hearing) disorders, nausea or vomiting, sensation of pressure or ringing in the ears. Gentalek may also cause kidney dysfunction. Inform your doctor if you notice a significant decrease in the amount of urine you excrete.

Rare (may occur in fewer than 1 in 1000 patients): muscle pain, reduced blood levels of calcium, potassium and magnesium, neuromuscular transmission blockade, rash, itching (pruritus).

Very rare (may occur in fewer than 1 in 10,000 patients): palpitations (feeling of strong heart beats), headache, tiredness, paresthesia (sensations of tickling, itching or tingling without an apparent cause), visual disturbances, elevated body temperature, anaphylactic reaction (manifested as respiratory distress and swelling), anaemia, changes in blood cell levels. Elevated serum bilirubin levels and increased activity of liver enzymes (transaminases) may also be present.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or other medical staff.

 

5. STORAGE OF GENTALEK

Keep out of the reach and sight of children!

Do not use Gentalek after the expiry date imprinted on the package. The expiration refers to the last day of the imprinted month.
Store below 25 °C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.

 

6. FURTHER INFORMATION

What Gentalek contains

– The active substance is gentamicin in the form of gentamicin sulfate. 1 ml of solution for injection/infusion contains 10, 20, 40 or 60 mg of gentamicin in the form of gentamicin sulfate.

– Excipients: disodium edetate, methyl parahydroxybenzoate (E21 8), sodium metabisuffite (E223), propylene glycol, propyl parahydroxybenzoate (E216), sodium hydroxide (for pH adjustment), sulphuric add (for pH adjustment), water for injections.

 

What Gentalek looks like and contents of the pack

Gentalek is a solution for injection/infusion. The solution is colourless to almost colourless, clear and free of visible particles.

The medicine is available in different pack sizes containing 10 ampoules of 80mg/2ml.

 

Availability of Gentalek

The medicine is available only with a prescription and is intended for hospital use only.

 

Manufacturer

Lek PharmaceutIcals d.d., Verovskova 57, 1526 Ljubljana,

Slovenia

 

Marketing authorisation holder

Novartis Nigeria Limited

Mansard Place, 4th Floor, Bishop Aboyade Cole Street

Victoria Island, Lagos, Nigeria

 

This leaflet was last approved in November, 2016